Evaluating Error Augmentation for Neurorehabilitation (VREA)

This study has been completed.
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
James Patton, Rehabilitation Institute of Chicago
ClinicalTrials.gov Identifier:
NCT01574495
First received: February 28, 2012
Last updated: June 10, 2013
Last verified: June 2013
  Purpose

This is a sub-project of a larger NIDRR Grant. One promising form of robotic training that leverages the power of neuro-plasticity is error augmentation. In this paradigm the computer singles out and magnifies a stroke survivor's movement errors from a desired trajectory, thus forcing the subjects to strengthen their control. Using the VRROOM, a state-of-the-art system which uses haptics (robotic forces) and graphics (visual display) interfaces, a subject's desired trajectory can be determined and the movement errors can be amplified in real-time with dramatic results. This project evaluates a practical approach of error augmentation, using therapist-driven trajectories. The investigators intend to determine clinical efficacy of several types of therapist-assisted error augmentation on retraining the nervous system in functional activities. The investigators will test two experimental treatments in a crossover design. The investigators hypothesize that combined haptic and visual error augmentation will lead to the best functional recovery.


Condition Intervention
Stroke
Other: Error Augmentation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating Error Augmentation for Neurorehabilitation

Resource links provided by NLM:


Further study details as provided by Rehabilitation Institute of Chicago:

Primary Outcome Measures:
  • Arm motor recovery scores on the Fugl-Meyer [ Time Frame: Change from baseline in Fugl-Meyer to 11 weeks (with assessment periods occurring at 2 weeks, 3 weeks, 4 weeks, 6 weeks, 7 weeks, and 11 weeks) ] [ Designated as safety issue: No ]
    Change from baseline in arm motor recovery as measured by Fugl-Meyer


Secondary Outcome Measures:
  • Number of blocks transferred in Box and Blocks Test [ Time Frame: same as primary ] [ Designated as safety issue: No ]
    Change from baseline in number of blocks transferred during Box and Blocks Test

  • Time and Quality of movement scores on the Wolf Motor Function Test [ Time Frame: same as primary ] [ Designated as safety issue: No ]
    Change from baseline in arm motor recovery as measured by time scores and ability scores on the Wolf Motor Function test

  • Time scores and Ability scores on the Assessment of Simple Functional Reach Test [ Time Frame: same as primary ] [ Designated as safety issue: No ]
    Change from baseline in arm motor recovery as measured by time scores and ability scores on the Assessment of Simple Functional Reach Test


Enrollment: 40
Study Start Date: January 2008
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Error Augmentation-Control Other: Error Augmentation
error augmentation for arm motor recovery in individuals with stroke
Other Names:
  • Error Augmentation-Control
  • Control-Error Augmentation
Experimental: Control-Error Augmentation Other: Error Augmentation
error augmentation for arm motor recovery in individuals with stroke
Other Names:
  • Error Augmentation-Control
  • Control-Error Augmentation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • adult (age >18)
  • survived a single cortical stroke at least 6 months previously involving ischemia or hemorrhage of the middle cerebral artery (MCA),
  • demonstrated the presence of some active shoulder and elbow movement (characterized by Fugl-Meyer Assessment Upper Extremity scores ranging from 15-50).

Exclusion Criteria:

  • diffuse or multiple lesion sites or multiple stroke events
  • bilateral paresis
  • severe spasticity or contracture (Modified Ashworth ≥3
  • severe concurrent medical problems
  • severe sensory deficits
  • cerebellar strokes resulting in severe ataxia
  • significant shoulder pain
  • focal tone management with Botulinim Toxin (Botox®) injection to the hemiparetic upper extremity (UE) within the previous four months,
  • aphasia that would influence the ability to perform the experiment
  • cognitive impairment (Mini Mental State Examination < 23/30)
  • affective dysfunction that would influence the ability to perform the experiment
  • depth perception impairment (< 3 on Stereo Circle Test)
  • visual field cut or hemispatial neglect that would influence the ability to participate in the activity
  • inability to provide informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01574495

Locations
United States, Illinois
Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Rehabilitation Institute of Chicago
U.S. Department of Education
Investigators
Principal Investigator: James Patton, PhD Rehabilitation Institute of Chicago
  More Information

No publications provided

Responsible Party: James Patton, Co-Director, Robotics Laboratory, Sensory Motor Performance Program, Rehabilitation Institute of Chicago, Rehabilitation Institute of Chicago
ClinicalTrials.gov Identifier: NCT01574495     History of Changes
Other Study ID Numbers: H133E0700 13, STU00002311
Study First Received: February 28, 2012
Last Updated: June 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Rehabilitation Institute of Chicago:
stroke
error augmentation
arm recovery
massed practice

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014